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Clinical Trial Summary

The objective of the study is to evaluate the effect of spironolactone on 16 patients presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate whether spironolactone can resolve sub retinal fluid in these patients.

CSCR is a major cause of visual loss in the young population. It is characterized by sub retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes of the disease remain unknown but a choroidopathy has been suggested. Moreover, corticotherapy and stress are known risk factors of CSCR.

Our preclinical studies have demonstrated that the mineralocorticoid pathway could be involved in the control of choroidal blood flow.

The investigators propose to evaluate the mineralocorticoid receptors antagonist spironolactone in the treatment of CSCR.

Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint: visual acuity gain ≥ 15 EDTRS letters


Clinical Trial Description

This is a prospective placebo controlled cross over study including 16 patients ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01552044
Study type Interventional
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2012
Completion date February 2013